Devices

Device Recall Dimension Vista Mass Creatine Kinase (MMB) Flex

Model / Serial
MMB, colorimetric method, cpk or isozymes, K6420, SMN# 10445097 Lot codes: 16284BD 16312BB 17011BD 17058BD 17093BC 17136BE 17186BE 17235BC 17268BA
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada, Mexico, and Thailand
Product Description
Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
Manufacturer
Siemens Healthcare Diagnostics, Inc.
1 Event
- Recall of Device Recall Dimension Vista Mass Creatine Kinase (MMB) Flex

Manufacturer

Siemens Healthcare Diagnostics, Inc.

Manufacturer Address
Siemens Healthcare Diagnostics, Inc., 511 Benedict Ave, Tarrytown NY 10591-5005
Manufacturer Parent Company (2017)
Siemens Ag
Source
USFDA

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